Bringing new rotavirus vaccines quickly to market
PATH is helping advance development of two new vaccines that could prove both affordable and effective in the developing world. One, the 116E human monovalent vaccine, is being developed by the Indian manufacturer Bharat Biotech International, Ltd. (BBIL). Seven emerging country manufacturers (and one US company) are working to develop the second new candidate, known as the human bovine reassortant vaccine.
Bharat Biotech International, Ltd.
For the past five years, PATH has been part of a collaborative effort to develop a vaccine known as the 116E vaccine. This collaboration emerged from the Vaccine Action Program—a cooperative effort of the US and Indian governments—and drew on the seminal efforts of several leading experts in the rotavirus field. In India, we drew on the expertise of the Department of Biotechnology in the Ministry of Science and Technology, the Indian Institute of Science in Bangalore, the All India Institute of Medical Sciences in New Delhi, the National Institute of Immunology, and the Society for Applied Studies. In the United Sates, we drew on the expertise of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and Stanford University. PATH is currently supporting BBIL’s work on early-stage clinical trials.
Shantha Biotechnics, Ltd., and Wuhan Institute of Biological Products
PATH is closely partnering with two manufacturers—Shantha Biotech in India and the China National Biotec Group’s Wuhan Institute of Biological Products—to provide financial support and developmental assistance to advance the development of a human bovine reassortant vaccine. This rotavirus vaccine, containing components developed by the NIH, is designed to protect against rotavirus disease strains that have emerged more recently in Asia and Africa, and it can be updated as new strains emerge.
In addition, PATH is supporting the development of a “shared technology platform” that would be made available to all the manufacturers working in earnest and meeting development milestones on the human bovine reassortant vaccine. This toolbox of technologies, training, and common technical support will help to maximize the production capacity and global availability of rotavirus vaccine. PATH is working with the following partners on the components of the “shared technology platform.”
- US National Institutes of Health
The NIH developed components of the human bovine reassortant vaccine, including specific rotavirus disease strains that are of long-term importance as well as strains that have emerged more recently in Asia and Africa. - Murdoch Children’s Research Institute
The Murdoch Children’s Research Institute will produce, qualify, and make available products (assays and reagents) that test for purity and consistency in the various components of the vaccine. - Charles River Laboratories
Charles River Laboratories will perform the testing necessary to ensure that key vaccine ingredients, including virus seeds and other basic components, meet established international guidelines. - ATCC
Vaccine manufacturers need cell cultures to grow the virus for vaccine production. ATCC is providing the “starting material” cell banks (a qualified passage Vero cell line) that meets international standards for production of biological products. - Aridis Pharmaceuticals
Aridis Pharmaceuticals is working on stable liquid and spray-dried formulations that will be well suited to administration of the vaccines in low-resource countries.